FDA asks for fees from industry to fund FSMA

In This Section

June 2013

In April 2013, the US Food and Drug Administration (FDA) released a budget request that called for industry “user fees” to fund 94% of the agency’s proposed budget increase over the previous fiscal year, including new fees to support the Food Safety Modernization Act (FSMA) and strengthen the FDA’s ability to oversee imported food. FSMA was signed into law in January 2011 and is still in the process of being implemented.

The budget includes spending cuts in several areas, the agency said, including a $15 million decrease in budget authority for human drug, biologics, and medical device programs.

“These investments will provide industry with consistent and transparent food and feed safety guidance to assure the safety of America’s food and feed supply,” the agency states in its budget proposal. It also asserts the price “is modest compared to the economic value it can deliver: reduced costs to industry, government, and the health care system due to less foodborne illness.”

There are 48 million food-borne illnesses each year, FDA said, which lead to 128,000 hospitalizations and 3,000 deaths, at a total estimated cost of more than $78 billion.

The six new fees, according to the proposal, are:

Food import user fee: This fee will support food and feed safety efforts and will have exemptions for small importers and a maximum charge for large importers. The number of food and feed imports has been growing by 10% each year, according to the agency. With more than 100,000 food and feed manufacturers in 130 countries exporting products to the United States, FDA is “hard-pressed to ensure safety.”

Food facility registration and inspection user fee: This fee will support food and feed safety modernization activities under FSMA, the proposal said. The revenue will allow the agency “to increase the effectiveness of inspections through adoption of preventive controls, training of personnel to inspect against the new prevention standards, and developing new ways to educate and inform industry,” according to the agency.

Food contact substance notification user fee: The FDA Modernization Act of 1997 established a premarket notification process for food contact substances known as the Food Contact Notification (FCN) program. The legislation requires that the FCN program can operate only if it is adequately funded; thus, this suggested new fee.

The final three new user fees are not related to food and feed safety. Rather, they involve cosmetics, medical product reinspections, and the need to fund increased surveillance of FDA-regulated commodities, predominantly medical products, at express courier hubs.